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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Kothari 2000.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 47.9

  • Weight (mean ± SD, median (IQR), median (range)): 87.5

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 22/24/4/0

  • Gender (female in %): 72

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA/24

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 65.1

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: laparoscopic cholecystectomy


Dimenhydrinate
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 58

  • Age (mean ± SD, median (IQR), median (range)): 49.7

  • Weight (mean ± SD, median (IQR), median (range)): 85.1

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 25/27/6/0

  • Gender (female in %): 74.14

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA/22.41

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 61.1

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: ASA I to III, undergoing elective laparoscopic cholecystectomy
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 34% (patients given their choice of antiemetic at the discretion of the anaesthesiologist)


Dimenhydrinate
  • Dose: 50 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 29% (patients given their choice of antiemetic at the discretion of the anaesthesiologist)

Outcomes Vomiting (0 to 24 hours)
  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)
  • Outcome type: dichotomous outcome


Subjects with any AE (0 to 24 hours)
  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)
  • Outcome type: dichotomous outcome


Sedation/drowsiness (0 to 24 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: NA
Country: USA
Setting: inpatient, single‐centre
Author's name: W.C. Boyd
Institution: Departments of Surgery and Anesthesiology, Gundersen Lutheran, La Crosse, WI 54601, USA
Email: AN
Address: Departments of Surgery and Anesthesiology, Gundersen Lutheran, 1836 South Avenue, La Crosse, WI 54601, USA
Duration of study: 1 November 1998 to 1 June 1999
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: quote: "randomization was performed using a computer‐generated randomized list''
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "nurses blinded to which antiemetic the patients had received recorded all episodes of nausea, vomiting, and retching in the recovery room by direct questioning, spontaneous complaint of the patient, or side effects''
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: quote: "of the 20 patient excluded, 15 had received an additional antiemetic preoperatively 4 were converted to open cholecystectomy, and the case of 1 was aborted because of the intraoperative finding of carcinomatosis. Of the 108 remaining patients available for analysis, 50 [of] whom were randomized to receive ondansetron (group 1) and 58 to receive dimenhydrinate (group 2)''
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Judgement comment: quote: "patient demographics were similar in both treatment groups"
Baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear